Heart Failure Clinical Trial
— PWA-HFOfficial title:
Pulse Wave Analysis in Advanced Heart Failure Patients Before and After Ventricular Assist Device
NCT number | NCT01642927 |
Other study ID # | FWA00000312-7 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | February 2012 |
Est. completion date | December 2016 |
Verified date | April 2023 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A comparison of pulse wave characteristics, as measured by peripheral tonometry, in pre and post Left Ventricular Assist Device (LVAD) patients.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1)18 years of age or older 2)Advanced heart failure as defined by need for IABP or LVAD 3)One or more of the following: - Current inpatient heart failure treatment with intra-aortic balloon pump (IABP)-IABP Group •= 1 week post-LVAD implantation with current IABP support-IABP/LVAD Group •= 3 mo post-LVAD placement and scheduled for LVAD speed optimization with echocardiography.-Post-LVAD Group - Post-LVAD placement with suspected GI hemorrhage or LVAD thrombosis-LVAD Event Group 4)Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Exclusion Criteria: 1. Clinical status will not permit pause of IABP (IABP and IABP/LVAD Groups) 2. Unable to undergo echo or oversewn or patched aortic valve (Post-LVAD Group) |
Country | Name | City | State |
---|---|---|---|
United States | Univeristy of Minnesota Lillehei Heart Institute | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Observation of pulse wave signatures in LVAD patients | ongoing |
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